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| Name | Class |
|---|---|
| Foundation for Chiropractic Education and Research (FCER) | OTHER |
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This randomized clinical trial pilot study will investigate the efficacy of different amounts of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects will be evenly randomized into four groups of either flexion distraction (FD) care or a control: Group 1 with 8 total FD treatment visits, Group 2 with 12 total FD treatment visits, Group 3 with 18 total FD treatment visits, or Group 4 with 8 total placebo control visits. The study is designed: (1) To determine the feasibility of a larger scale study in terms of logistics, recruitment efforts, and sample size estimations and (2) To determine among the three treatment groups the change in perceived pain levels and general functional health status at the end of six weeks of treatment and at three months post care as follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 8 flexion distraction visits |
|
| 2 | Active Comparator | 12 flexion distraction visits |
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| 3 | Active Comparator | 18 flexion distraction visits |
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| 4 | Placebo Comparator | 8 placebo control visits |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flexion distraction | Procedure | Chiropractic treatment using the flexion distraction apparatus |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain | 6 weeks; 3 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional health status | 6 weeks; 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerrilyn Cambron, DC, PhD | National University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Health Sciences | Lombard | Illinois | 60148 | United States |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| placebo control | Other | Placebo for comparison with flexion distraction treatment |
|